Drug-induced hypersensitivity syndrome in Japan in the past 10 years based on data from the relief system of the Pharmaceuticals and Medical Devices Agency.
Drug-induced hypersensitivity syndrome in Japan in the past 10 years based on data from the relief system of the Pharmaceuticals and Medical Devices Agency.
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根据医药品医疗器械综合机构救济系统的数据，近 10 年日本药物引起的过敏综合症。
DOI：
10.1016/j.alit.2016.09.003
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发表时间：
2017
期刊：
影响因子：
--
通讯作者：
M. Iijima
中科院分区：
文献类型：
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作者：
Yuri Kinoshita;H. Saeki;A. Asahina;T. Ochiai;M. Iijima
药物诱导的超敏反应综合征（DIHS）的特征是有限数量的致病药物，延迟发作，停用致病药物后临床症状恶化，几种疱疹病毒的连续再激活，以及在临床消退后很长时间内发生几种器官系统衰竭。1，2引起DIHS的药物包括卡马西平、苯妥英、苯巴比妥、唑尼沙胺、美西律、二苯砜（dapson）、柳氮磺胺吡啶和别嘌呤醇。2，3迄今为止，DIHS的数据主要通过参考已发表的文章或会议摘要收集。日本设有药品和医疗器械管理局（PMDA）管理的药物不良反应（ADR）患者救济制度，为适当使用相关药物的严重ADR患者提供救济福利。4近年来，DIHS在皮肤ADR中的比例显著增加，可能是因为这种类型的ADR已变得众所周知。5我们分析了10年期间来自PMDA救济系统的DIHS患者的公开数据（http：//www.pm.org/hk/hk/hk/）。pmda。走了jp/relief-services/index. html），并阐述了这一ADR的最新趋势。采用c2检验分析数据，认为p< 0.05有统计学意义。表1显示了过去10年DIHS病例的摘要。在此期间，这些病例总数为835例，其中51例死亡（死亡率：6.1%）。图1a描述了2006至2015财年的DIHS案例数量，显示出数量呈逐年增加的趋势。前5年（2006 - 2010财年）有299家，后5年增加到536家（2011 - 2015财年，表1）。图1 B显示了2006至2015财年DIHS病例的死亡率，显示其因年份而异，从0.0%到14.6%不等。前5年（6.0%）和后5年（6.2%）的平均死亡率几乎相同（表1）。值得注意的是，最近两年的死亡率非常低，2014年和2015年分别为2.8%和0.0%。在总计835例患者中，438例（52.5%）为男性，397例（47.5%）为女性。最常见的年龄为60 ~ 69岁（20.6%），其次为40 ~ 49岁（19.3%）、30 ~ 39岁（16.0%）、50 ~ 59岁（14.7%）、70 ~ 79岁（11.9%）和20 ~ 29岁（9.1%）。致病药物总数为959种，包括同一患者的重叠药物。最常见的致病药物类型是抗惊厥药（61.8%），其次是抗高尿酸血症药（10.0%）、肠道疾病治疗药（8.8%）、抗生素（4.9%）、抗精神病药（4.8%）、抗精神病药（3.5%）和抗麻风病药（2.4%）。抗精神病药使用率1.8%比6.5%（P<0.001），后5年抗生素使用率明显高于前5年（6.3%比2.5%，P<0.05）。就个别药物而言，最常见的致病药物是卡马西平（35.1%，抗惊厥药），其次是别嘌呤醇（10.0%，抗高尿酸血症药），拉莫三嗪（9.3%，抗惊厥药），柳氮磺胺吡啶（8.4%，一种肠道疾病治疗剂），盐酸美西律（4.8%，一种抗疟疾药物），唑尼沙胺（4.7%，抗惊厥药），苯巴比妥（4.5%，抗惊厥药），苯妥英（4.4%，抗惊厥药），丙戊酸钠（3.3%，抗惊厥药），二苯砜（2.4%，一种抗麻风病药物）、氯丙嗪、丙嗪、苯巴比妥（2.1%，一种抗精神病药物）和磺胺甲恶唑甲氧苄啶（2.0%，一种抗生素）。拉莫三嗪的百分比在后5年显著高于前5年（14.2% vs. 0.8%，p< 1 10 10），
Drug-induced hypersensitivity syndrome (DIHS) is characterized by a limited number of causal drugs, delayed onset, worsening of clinical symptoms after discontinuation of the causal drugs, sequential reactivations of several herpesviruses, and development of several organ system failures long after clinical resolution. 1, 2 The causal drugs of DIHS include carmabazepine, phenytoin, phenobarbital, zonisamide, mexiletine, diaphenylsulfone (dapson), salazosulfapyridine and allopurinol. 2, 3 The data of DIHS have been collected to date mostly by referring to published article or meeting abstracts. Japan has a relief system for sufferers from adverse drug reactions (ADRs) managed by the Pharmaceuticals and Medical Devices Agency (PMDA) which provides relief benefits for patients with severe ADRs in the appropriate use of the drugs concerned. 4 In recent years the proportion of DIHS among cutaneous ADRs has significantly increased probably because this type of ADR has become well known. 5 We analyzed the open data on DIHS patients from the relief system of the PMDA during a 10-year period (http://www. pmda. go. jp/relief-services/index. html) and elucidated the recent trend of this ADR. The c2-test was used to analyze the data, and p< 0.05 was considered statistically significant. Table 1 shows a summary of DIHS cases in the past 10 years. The total number of these cases during the period was 835 of which 51 had died (mortality rate: 6.1%). Figure 1 a depicts the number of DIHS cases from fiscal year (FY) 2006e2015, disclosing that the number tended to increase year by year. There were 299 in the first 5 years (FY 2006e2010), whereas these increased to 536 in the latter 5 years (FY 2011e2015, Table 1). Figure 1 b shows the mortality rates of DIHS cases from FY 2006 to 2015, revealing they varied from 0.0% to 14.6% depending on the year. The average mortality rates in the first 5 years (6.0%) and the latter 5 years (6.2%) were almost the same (Table 1). Of note, the mortality rates in the most recent two years were very low, with 2.8% and 0.0% in FS 2014 and 2015, respectively. Of the total of 835 patients, 438 (52.5%) were males and 397 (47.5%) were females. The most frequent ages were 60e69 years (20.6%), followed by 40e49 (19.3%), 30e39 (16.0%), 50e59 (14.7%), 70e79 (11.9%) and 20e29 (9.1%). The total number of causal drugs was 959 including overlapping drugs in the same patient. The most frequent type of causal drug was anticonvulsants (61.8%), followed by antihyperuricemics (10.0%), bowel disease treating agents (8.8%), antibiotics (4.9%), antiarrhythmic drugs (4.8%), antipsychotic drugs (3.5%) and antileprosy drugs (2.4%). The percentage of antibiotics was significantly higher in the latter 5 years than in the first 5 years (6.3% vs. 2.5%, p< 0.05), and that of antipsychotic drugs was significantly lower (1.8% vs. 6.5%, p< 0.001). With regard to individual drugs, the most frequent causal drug was carbamazepine (35.1%, an anticonvulsant), followed by allopurinol (10.0%, an antihyperuricemic), lamotrigine (9.3%, an anticonvulsant), salazosulfapyridine (8.4%, a bowel disease treating agent), mexiletine hydrochloride (4.8%, an antiarrhythmic drug), zonisamide (4.7%, an anticonvulsant), phenobarbital (4.5%, an anticonvulsant), phenytoin (4.4%, an anticonvulsant), sodium valproate (3.3%, an anticonvulsant), diaphenylsulfone (2.4%, an antileprosy drug), chlorpromazineepromethazineephenobarbital (2.1%, an antipsychotic drug) and sulfamethoxazoleetrimethoprim (2.0%, an antibiotic). The percentage of lamotrigine was significantly higher in the latter 5 years than in the first years (14.2% vs. 0.8%, p< 1 Â10À10), and …
DOI：
10.2332/allergolint.55.1
发表时间：
2006-03-01
期刊：
Allergology international : official journal of the Japanese Society of Allergology
影响因子：
--
作者：
Shiohara, Tetsuo;Inaoka, Miyuki;Kano, Yoko
通讯作者：
Kano, Yoko